📋FDA Guidance on Accelerated Drug Approval and Confirmatory Trials
Accelerated Approval and Considerations for Determining Whether a Confirmatory Trial is Underway; Draft Guidance for Industry; Availability
Summary
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "Accelerated Approval and Considerations for Determining Whether a Confirmatory Trial is Underway." For drugs granted accelerated approval, sponsors conduct confirmatory studies that must be completed postapproval to verify and describe the anticipated effect on irreversible morbidity or mortality or other clinical benefit. This draft guidance describes FDA's interpretation of the term "underway" and discusses policies for implementing this requirement, including factors FDA intends to consider when determining whether a confirmatory trial is underway prior to accelerated approval.
Agencies
- Health and Human Services Department
- Food and Drug Administration
Business Impact
$$ - Med
The guidance outlines new compliance requirements for companies seeking accelerated drug approvals, mandating confirmatory trials underway before approval. This impacts drug sponsors by increasing regulatory oversight and necessitating adjustments in study timelines and reporting frequency, thus influencing business strategies and operational procedures.